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Antibiotic-resistant bacteria are on the rise. At the same time, antibiotic drug development has slowed to a crawl. We’re definitely in trouble and must preserve our last antibiotics.

Little did I know when I set out to report this story last February for the Canadian Journal of Medical Laboratory Science that within days, the World Health Organization would publish a list of a dozen antibiotic-resistant superbugs that pose the greatest threat to human health. The WHO warned drug manufacturers and frontline infection-control healthcare workers to focus on the most dangerous superbugs first.

Then my story sources told me about a patient who was infected with a superbug listed near the top of the critical list. The story arc for the article fell neatly into place.

Antibiotic-resistant bacteria have several nasty tricks up their sleeves to evade destruction. They can develop cellular pumps that push infiltrating antibiotics back out. Some produce a slimy coating to avoid detection. Others even swap plasmids, small rings of DNA, with other bugs to pass on antibiotic-resistance superpowers.

What does good antibiotic stewardship involve? A team approach coordinated between infectious disease doctors, nurses and medical laboratory technologists can help identify the pathogen quickly, establish susceptibility and ensure treating patients with the right drug for the right length of time.

The next time you feel like pressing your doctor for an antibiotic prescription for the flu or the common cold, think again. Antibiotics are not necessarily required in surgeries either: my surgeon did not prescribe any before or after my foot surgery for cartiva implants in both feet nine months ago.

Click on the story below to read how the healthcare team helped this patient who was out of all other options.

On August 18, 2015, the FDA approved Addyi (flibanserin), a drug to treat “acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.” The FDA defines HSDD as “low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of medication or other drug substance.”

That’s an interesting parsing of words since some of those parameters may not be mutually exclusive. (And what about situations where men are no longer desirable because of issues related to THEM?)

Much has been written in the last week in light of the FDA approval for Addyi. There are so many things that have me shaking my head. My first thought? Equality is nowhere near the same thing as equity.

It’s not “female Viagra.”

If you were following the news over the last two weeks, you likely heard Addyi referred to as the “female Viagra,” yet the FDA announcement said, “Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.”

Over at FierceBiotech, John Carroll says the FDA blundered badly on the Addyi approval and says that manufacturer Sprout Pharmaceuticals is benefitting from the viral hype around the “female Viagra” terminology. The FDA never invoked the “female Viagra” wording, but there was a concerted effort by the manufacturer to market a drug for female sexual disorder and others have written about how this drug approval rode in on the tide of the efforts by Even the Score, a collaborative initiative by “26 Organizations who believe that it’s time to level the playing field when it comes to the treatment of women’s sexual dysfunction.”

The manufacturer has no idea how Addyi works.

Originally an antidepressant that failed to win approval two times over, the drug works in the brain by altering neurotransmitters. However, the prescribing information states that the mechanism of action is unknown. This is disappointing, however not unusual given that there are a lot of drugs that have unknown mechanisms of action, e.g. anesthesia.

A lot of fuss and risk for a little more frisk.

provides women who respond with less than one more sexually satisfying events per month (0.5-0.7)

is recommended to be taken at bedtime because it has a sedating effect on the central nervous system: “Patients should not drive or engage in other activities requiring full alertness until at least 6 hours after taking Addyi and until they know how Addyi affects them.” (But what about women who would like to enjoy sex fully alert? Should they set an alarm for 4 am? Or plan for afternoon escapades?)

Second, she flagged for me that in the safety studies about alcohol, which were conducted among a small group of 25 people, 23 of the participants were MEN! Given that women are more susceptible to the toxic effects of alcohol than men, this is alarming. (This reminds me of the ridiculous refusal by some study authors last year to retract a paper from JAMA even after they admitted to including WOMEN in their study about the effects of testosterone replacement therapy and cardiovascular health in MEN…)

Is HSDD an invented disorder?

This paper in the Journal of Medical Ethics published online June 29, 2015 says that there is no established norm for sexual activity, feelings or desire, and concludes, therefore, that female hypoactive sexual disorder does not exist:

Condition branding is a marketing technique in which companies develop conditions concurrently with developing drugs; examples include gastro-oesophageal reflux disease, premenstrual dysphoric disorder, social anxiety disorder, erectile dysfunction and hypoactive sexual desire disorder. Although it is illegal for pharmaceutical companies to market drugs prior to regulatory approval, there are no restrictions on marketing diseases, and industry seeks to establish a disease state in the minds of clinicians years before an expected drug launch. Continuing medical education (CME) courses are an important part of promotion prior to drug approval and have become a key marketing tool for increasing clinician receptivity to new products. We systematically identified 14 free, internet-based, industry-funded, accredited CME modules on hypoactive sexual desire disorder in women which came out before a new drug, flibanserin, was being considered for regulatory approval in the USA. Common themes in these modules included the following: (1) Hypoactive sexual desire disorder is common, underdiagnosed and can have a profound effect on quality of life. (2) Women may not be aware that they are sick or distressed. (3) Simple questionnaires can assist clinicians in diagnosing the disorder. (4) It is problematic that there are medicines available to treat sexual problems for men but not women. In fact, there is no scientifically established norm for sexual activity, feelings or desire, and there is no evidence that hypoactive sexual desire disorder is a medical condition. Hypoactive sexual desire disorder is a typical example of a condition that was sponsored by industry to prepare the market for a specific treatment. (Bold emphasis mine).

Nomenclature follies.

Why is there no mention in Addyi’s prescribing information for the condition needing to be present for at least six months before diagnosing a woman with the disorder? The FDA’s summary of patient impact and scientific meetings held last October stated that HSDD falls under female sexual interest/arousal disorder (FSIAD) in the Fifth Edition of the Diagnostic and Statistical Manual (DSM-5), and mentioned the fact that the disorder needs to be present for 6 months before diagnosis. Yet there is no mention of this in the prescribing information that I can see.

The FDA approval was for HSDD, and the FDA meetings held last October discussed female sexual dysfunction (FSD) as an umbrella term: “The term FSD covers a heterogeneous collection of conditions that have previously been classified into four different disorders: hypoactive sexual desire disorder (HSDD) characterized by a reduced or absent interest in sexual activity, female sexual arousal disorder (FSAD) characterized by an inability to attain or maintain sexual excitement, female orgasmic disorder characterized by the difficulty to attain orgasm despite sufficient arousal, and sexual pain disorder characterized by pain during sexual intercourse.

In May 2013, HSDD and FSAD were combined into a single diagnosis of female sexual interest/arousal disorder (FSIAD) in the Fifth Edition of the Diagnostic and Statistical Manual (DSM-5). For a woman to be diagnosed with FSIAD, her symptoms of reduced sexual interest/arousal must have been present for at least six months, and must be severe enough to be a source of personal distress. FSIAD can be lifelong or acquired, range from mild to severe, and may be generalized or situational. There is currently no precise measure of the prevalence of FSIAD. However, one survey of U.S. women found that 12% of women reported experiencing personally distressing sexual problems. (Bold emphasis mine). Source: (PDF) The Voice of the Patient, A series of reports from the U.S. Food and Drug Administration’s (FDA’s) Patient-Focused Drug Development Initiative, Female Sexual Dysfunction Public Meeting: October 27, 2014 Report Date: June 2015.

What’s next for Addyi?

Health Canada often follows FDA approval, but not always. Interestingly, two days after the FDA approval, Addyi’s manufacturer, Sprout Pharmaceuticals of Raleigh, North Carolina was bought for $1 billion by Canadian company Valeant. The company plans to request Health Canada approval this fall.

Rapid advances in the field of genetics are raising a host of questions and story ideas for health reporters to cover.

On April 24, 2015 at the Health Journalism 2015 conference in Santa Clara, California, four panelists spoke about where the field of genetics stands today and discussed the controversies and questions that need to be addressed as the field progresses. The panel was officially called the Clinical, Ethical and Research Sides of Genetics.

This panel was fascinating! My net takeaway is that the science has been moving faster than regulatory bodies can keep up in some areas, and slower than we would like for people facing life-threatening diseases.

The panel was organized and moderated by Scott Hensley, co-host of NPR’s Shots blog. The panelists were:

Emily Drabant Conley, Ph.D., director of business development at 23andMe, a direct-to-consumer genetic testing company based in Mountain View, California

David Magnus, Ph.D., director of the Stanford Center for Biomedical Ethics (and other appointments)

Henry T. Greely, director of the Center of Law and Biosciences at Stanford University (and other appointments)

Much ground was covered in the 90-minute session — way too much for one blog post! I have summarized the things I found the most interesting from the first two speakers here in Part 1, and posted highlights from the last two speakers in Part 2.

Dr. Conley: Update on 23andMe

The FDA has relaxed their stance on consumer genetic tests in response to increasing evidence that consumers are able to understand the difference between risks and outcomes.

First, before I outline what Dr. Conley presented, here is some background information for context. In November 2013, the FDA ordered 23andMe to stop selling direct-to-consumer genetic tests in the U.S. At the time, the FDA cited concerns for the potential health consequences that could result from false positive or false negative assessments for high-risk indications, such as BRCA-related ovarian and breast cancers, and the potential for patients to self-manage dosages or abandon drug therapies altogether without physician consultation, which could be dangerous for some drugs.

Dr. Conley spoke about the recent approval to market the test in the U.S. and what led to the change in stance by the FDA. In February 2015, the FDA issued the first approval ever for 23andMe to market a test for Bloom Syndrome, stating that in many circumstances, it’s not necessary for consumers to go through a licenced practitioner to access DNA information. The test has the potential to provide people with information about autosomal recessive disorders, where possible mutations in parents’ genes can possibly be passed on to their children. Dr. Conley discussed the independent study results that formed the basis of the FDA submission and said, “We needed to first demonstrate that the test is accurate, and secondly, that users could comprehend this information. Not just savvy, sophisticated users, but that average users could interpret the results and make sense of them.” The findings she presented were quite compelling.

I found it interesting how regulatory bodies in the U.S. and Canada have taken different approaches to the ethical considerations of consumers understanding the difference between risks and outcomes. When a pared-down version of the test was launched in Canada in October 2014, Health Canada passed the buck to the provinces to determine if medical and privacy information would be handled adequately. But the horse had already left the stable: 20,000 Canadians had already ordered the broader range test kits from 23andMe’s website and imported them prior to the Canadian launch.

Consumer genetic tests are a stepping stone in a much bigger business plan for 23andMe.

In January 2015, 23andMe announced a new therapeutics division and signed billion dollar deals with Genentech and several pharmaceutical companies. The division’s focus is to develop targeted drugs using human genetic data, hopefully speeding up the development pipeline dramatically compared to traditional methods that start with animal research. Hear her speak in this interview for Bloomberg Business.

What does that mean? Consumers consent to allow 23andMe to use their genetic information, stripped of their identity to ensure privacy. You might think at first blush that most consumers would balk at the company selling their data to for-profit drug companies, but Dr. Conley said that the opt-in rate is 80 per cent.

Dr. Magnus: Ethical challenges of next-generation sequencing

Magnus drew a chuckle from the audience when he said his presentation would cover a different topic and he “wouldn’t compete with the infomercial” we had just seen from Drabant Conley. His work at Stanford focuses on examining ethical issues in reproductive technologies, organ transplantation and end of life issues in adults and children. His presentation focused on the broad ethical challenges that are arising as next generation sequencing moves into the clinic:

Informed Consent: As genetic testing has moved from information about a single trait to a larger panel of full sequencing, what does that mean for informed consent? For example, if non-invasive prenatal testing in a single process becomes the norm, is it necessary to seek informed consent across a whole range of disease possibilities? How should the uncertainty of results be communicated to people both before and after the results are available?

Risks: What are the risks of false positives? There has already been a case of false paternity from 23andMe test results.

Privacy Issues: Data management is a huge burden because genomic data is inherently identifiable. There have been cases where de-identified information has been combined with other data and individuals were identified. The HIPPA Privacy Rule actually requires a low risk of identifiability, not zero!

What Information Should Be Returned? Should only actionable findings or all findings be returned, even those of unknown significance? Who decides and controls the flow of information — patients, doctors, pathologists, hospital review boards?

The bottom line for me is this: Are we ready to know what we don’t know? What changes once we do?

They are gaining in popularity but are e-cigarettes safe? After spotting a young woman ‘vaping’ on the Toronto subway line a few weeks ago, I decided to take a look at the topic.

An electronic or e-cigarette is a cylinder-shaped canister made of plastic or stainless steel that looks like a regular cigarette. A little battery system heats and vaporizes a liquid, ‘smoke juice,’ which may contain nicotine, propylene glycol, polyethylene glycol or other chemicals. An indicator light glows during inhalation, similar to a regular cigarette. E-cigarettes are sold in various flavours, like menthol and cherry, liquor flavours like piña colada and peach schnapps, and candy flavours like chocolate, gummy bear and bubble gum. This ‘vapor bar’ in New York offers more than 80 flavours.

In Canada, e-cigarettes containing nicotine are not approved for sale, yet they can be purchased over the Internet. “Nicotine is a drug, and e-cigarettes containing nicotine are drug-delivery devices. Health Canada has always treated them as such, which makes Canada’s laws governing these devices among the most restrictive in the world,” says Matthew B. Stanbrook, MD, PhD, in a recent editorial in the Canadian Medical Association Journal.

South of the border in the United States it’s an entirely different story as e-cigarettes are currently sold there without any regulatory oversight. Manufacturers are spending heavily on celebrity endorsements, TV ads, NASCAR sponsorships, and product giveaways including starter packs in swag bags at the Oscars and starting this month, 1 million free products at nightclubs. The $1.5-$1.7 billion market tripled in size last year, but that growth may change soon because the FDA is expected to clamp down with new regulations as early as the end of October.

So are e-cigarettes safe?

E-cigarettes do not contain the tar and combustion ingredients that regular cigarettes have, but that doesn’t necessarily make them safe. Without regulation, nobody knows what chemicals they are actually inhaling, if those chemicals are safe or if labelling is accurate. Propylene glycol, for example, is a known irritant. The American Lung Association says, “In initial lab tests conducted by the FDA in 2009, detectable levels of toxic cancer-causing chemicals were found, including an ingredient used in anti-freeze, in two leading brands of e-cigarettes and 18 various cartridges.” The FDA also found that the nicotine delivered by one brand was highly variable from cartridge to cartridge.

Are e-cigarettes a good alternative for smokers who want to quit?

Maybe, but ‘safer’ and ‘safe’ are two entirely different things. And so far, the evidence for smoking cessation success is slim. One study in New Zealand, reported in The Lancet, showed that e-cigarettes were modestly effective for helping people quit compared to nicotine patches, with a success rate of 7.3% for e-cigarettes versus 5.8% for nicotine patches as measured at a six-month endpoint. Not exactly a panacea.

Nicotine is an addictive substance, no question there. Experts on both sides of the border are warning that this new nicotine delivery system could hook a new generation. The CDC is alarmed about the marketing efforts targeting youth as the percentage of adolescents using e-cigarettes doubled to 10% in 2012 compared to 4.7% the year before. “About 90 percent of all smokers begin smoking as teenagers,” said Tim McAfee, M.D., M.P.H., director of the CDC Office on Smoking and Health, “We must keep our youth from experimenting or using any tobacco product. These dramatic increases suggest that developing strategies to prevent marketing, sales, and use of e-cigarettes among youth is critical.”

The National Association of Attorneys General added significant heft to the need for regulation in a letter to the FDA, signed by more than 40 officials. Local governments like the state of New York and cities and towns north of Boston however, are tired of waiting for federal regulations and are looking at putting their own bans into place.

It will be interesting to see how the FDA rules on this in a few weeks. At a bare minimum, way more research needs to happen to answer key questions about product safety and whether e-cigarettes are good long-term alternatives for people who want to quit smoking.

There are 77 million American Baby Boomers and they are turning 63 at a rate of nearly one every seven seconds. Joseph Coughlin, Ph.D., and Director of AgeLab at the Massachusetts Institute of Technology (MIT), refers to Baby Boomers as “generation expectation” because they expect to live longer and better than previous generations.

Baby Boomers have grown up with many technological innovations and they expect technology to provide them with solutions to help maintain their independence for as long as possible. Some disability occurs with aging for about one-third of people over 65 in areas of hearing, vision, cognition, ambulation, self-care and independent living. While some of these disabilities are minor, some require accommodations or assistance to meet the demands of daily living.

Two areas where technology innovations are meeting the demand for increased independence among aging people are in-home remote healthcare and vehicle design.

The Care Innovations Guide is an innovative medical device that allows physicians to remotely monitor and care for patients at home. The device was cleared by the FDA in 2008 and was developed by Intel Corporation in partnership with GE. The Care Innovations Guide collects vital sign data, communicates patient reminders and multimedia educational content, and offers video conferencing and alert tools. The device can connect to certain models of medical equipment such as blood pressure monitors, glucose meters, pulse oximeters, peak flow meters and weight scales. Patients can use the device to take an active role in managing their health by monitoring their health stats, communicating with healthcare professionals and physicians, and learning more about their medical conditions.

In vehicle design, new technologies are helping older people drive safely longer, while improving the driving experience for other age groups as well. For many people, maintaining independence in older age means being able to continue driving safely, but attention capacity declines with age.

AgeLab uses two different test vehicle platforms to conduct research about how older people interact with cars. “Miss Daisy” is a fixed-base test vehicle used to evaluate cognitive distraction, as well as disease and medication effects by measuring eye movement, respiration, sweat gland activity and heart rate. “Miss Rosie” is a mobile test car outfitted with cameras and monitors that measure changes in spinal mobility, operator positioning, and the strength required for the driver to maneuver the car.

The objective of AgeLab’s vehicle research is to create a future “AwareCar”- one that senses driver distraction, fatigue or health status and intervenes to provide a safer ride. Built on learning about driver performance in test vehicles, the AwareCar of the future would assess changes in a driver’s performance, perhaps check their pulse, help with steering, tell them to put down their cell phone, or even remind them to take their medication.

AgeLab researchers and engineers have learned that it’s important to design technologies that are not just for older people, but that offer technology benefits for everyone. One vehicle research project measures the stress level of older adults operating a hands-free, ultrasound-assisted parallel parking system developed by Ford Motor Company. The parallel parking assist feature makes backing up easier for older adults who often have more limited neck mobility than when they were younger. Other features like blind-spot detection and a voice-activated audio system, however, are intended to appeal to a broad age-range of drivers with a general interest in smart technology.

Baby Boomers expect that technology will reinvent how they can maintain their independence for as long as possible. What activities do you expect to continue doing as you grow older?

CONNECT THE DOTS

Check out this video to see the Care Innovations Guide in action. Learn more about the innovations at MIT AgeLab or visit Joseph Coughlin’s blog, Disruptive Demographics to see a video about AGNES and Miss Daisy. For information about healthy aging, visit the AARP health page. You may also like our earlier post, New Insights into Healthy Aging from the Longevity Project. Click here to read more about GE’s joint venture with Intel.

Originally published on GE Healthy Outlook, August 24, 2011. Copyright Jane Langille.

It isn’t just about colas, coffee, or energy drinks anymore. Now there are more products appearing with added caffeine, the world’s most consumed pharmacologically active stimulant.

Last week I found this display of AWAKE Chocolate bars at my friendly neighbourhood Shoppers Drug Mart.

AWAKE Chocolate contains 101 mg of caffeine, promoted as having the same “whack” as a regular cup of coffee or 250 mL of energy drink. The caffeine is identified as a “medicinal ingredient” and the label states in tiny print that AWAKE “helps temporarily to relieve fatigue, to promote mental awareness, and to enhance cognitive and motor performance.”

The brainchild of three former consumer-packaged-goods marketers, AWAKE Chocolate was launched last August and is available in several major drug stores and grocery chains across Canada. According to the AWAKE Facebook page, the creators will be looking for a cash infusion for their business on an upcoming episode of Dragon’s Den set to air on February 10, 2013 on CBC at 8 p.m. The marketing campaign is aimed at 18-25 year olds and includes bus tour events to colleges and universities and a social media blitz.

But wait a minute…

The product is called AWAKE. Yet it states on the label, in tiny micro-type, that somehow passed regulatory clearance: “This product is not intended as a substitute for sleep.” Um…what?

Well, maybe there are many levels of consciousness between asleep and awake, but certainly none that might qualify as states of enhanced cognitive and motor performance. To further illustrate this main message logic gap, consider the Not AWAKE photo contest. University and college students are encouraged to post pictures of their hapless colleagues who fall asleep studying. The key message is that they should have eaten AWAKE Chocolate to avoid sleeping.

Sleep-deprived students might be far better off taking a nap rather than ingesting caffeine if they truly want to improve their perceptual learning and memory consolidation as found in this study from the Laboratory of Sleep and Behavioral Neuroscience at the University of California. Another study showed that a nap can be as good as a full night’s sleep for learning a perceptual task, handy knowledge if a student needs to manage the effects of an occasional all-nighter cramming for an exam.

Unfortunately, even though naps and proper sleep provide many health benefits and improved productivity, we live in a society that values 24 x 7 x 365 and any downtime is perceived as a sign of weakness. Young adults are fully capable of reading the fine print and making their own choices. But it may not be that simple.

A new U.S. report shows that the number of teens and young adults seeking emergency treatment after consuming energy drinks has doubled over the last four years and more than half those visits were for consumption of the energy drinks alone (42% of visits were in combination with alcohol or drugs.) Some of the notable adverse effects included anxiety, heart attacks and irregular heartbeats. A group of Canadian doctors are calling for a ban on the sale of energy drinks, such as 5-Hour Energy, to anyone under the age of 19, following the deaths of 13 young adults in the U.S. that are still under investigation by the FDA.

My biggest concern is that children of any age can buy AWAKE Chocolate and think they are getting a regular candy bar. Just one AWAKE bar exceeds the maximum recommended daily caffeine intake for children under the age of 12 years according to Health Canada’s “Information for Parents on Caffeine in Energy Drinks.”

I asked the pharmacist if she would sell a bar to a child and she said she would talk to them about why they were buying it and perhaps have a chat. But she said there was nothing restricting the sale of AWAKE Chocolate to children and most snack food purchases go through the registers at the front of the store, not the pharmacy counter. So cashiers are beeping an AWAKE bar through the scanner just like any other snack food.

Here’s the disclaimer language in tiny-type on the label, in light brown text on a dark brown background. Would you want your child to be able to buy this product?

Directions: Adults take 1 bar (44 g) as needed every 3-4 hours, up to 2 bars daily, or as directed by a health care practitioner. If security seal is missing or broken, do not use. For occasional use only. This product is not intended as a substitute for sleep. Consult a health care practitioner if you are of childbearing age, pregnant or breastfeeding. If you are taking lithium, or if you have high blood pressure, glaucoma, and/or detrusor instability (overactive bladder syndrome). Consumption with natural health products (e.g. bitter orange extract, synephrine octopamine, ephedra) or other drugs e.g. ephedrine, which increase blood pressure or other caffeine-containing products (e.g. medications, coffee, tea, colas, cocoa, guanana, maté) is not recommended. Hypersensitivity/allergy is known to occur, in which case, discontinue use. Caffeine may cause anxiety, tachycardia (rapid heart rate), palpitations, insomnia, restlessness, nervousness, tremor and headache.

The number of newly approved antibiotics has declined significantly since the 1980s as large pharmaceutical companies have mostly withdrawn from research and development in this critical market segment. Fortunately, the biotech industry is now stepping up to the plate to develop much-needed antibiotics to fight a rising number of drug-resistant superbugs, such as Clostridium difficile (or C. difficile).

Optimer Pharmaceuticals, Inc. of San Diego, CA recently received FDA approval for Dificid (fidaxomicin), a narrow spectrum antibiotic tablet to treat C. difficile-associated diarrhea. In clinical studies reported in the New England Journal of Medicine, patients treated with Dificid had a high cure rate of 90%, similar to standard vancomycin treatment, but with a significantly lower rate of recurrence: 13.3% versus the vancomycin group who showed a recurrence rate of 24.0%.

Dificid is the first in a new class of antibiotics called macrocycles, engineered to target C. difficile specifically. Sherwood Gorbach, MD, Chief Medical Officer for Optimer and co-author of the studies says, “because fidaxomicin is a narrow spectrum antibiotic, there is less likelihood to produce resistance, a problem we see with vancomycin.” Optimer holds patents for developing the unique fidaxomicin compound from a fungus found in soil.

The elderly and people in hospitals who have been treated with antibiotics are most at risk because C. difficile gets a chance to flourish and produce toxins in the gut after antibiotics have wiped out normal gastrointestinal flora. At any given time, about half of the patients in a hospital are receiving antibiotics.

The spread of infection can be difficult to contain as the spores can live outside the human body for a long time and may be found on hard surfaces such as bed linen or medical equipment. While C. difficile is mainly a hospital-acquired infection, about one-third of cases are found in long-term care facilities such as rehabilitation centers and nursing homes.

Recurrence is a significant problem as the symptoms are often worse than the original bout of infection. Gorbach emphasizes, “the reduction in the rate of recurrence is a significant advancement for patients with CDI. Fidaxomicin showed a sustained clinical response for 25 days, the period following treatment when most recurrences happen, in a greater number of cases vs. vancomycin.”

Another current therapeutic option for treating CDI is the off-label use of metronidazole, recommended by the CDC as an alternative to vancomycin. It has been around since the 1950s and has never been submitted to the FDA for approval for C. difficile treatment. Although not tested in clinical studies, according to Gorbach, Dificid offers a more promising treatment option, “Metronidazole is well absorbed, and so a lot of patients taking it experience side effects, whereas the side effects with fidaxomicin are very rare, because it is not readily absorbed.”

Recently in Canada, there have been more outbreaks of a hypervirulent C. difficile strain, variously referred to in the media as NAP1/BI/027. Over the past summer, that strain was responsible for an outbreak that led to more than 30 deaths in the Niagara, Ontario area. NAP1/BI/027 was the culprit identified between 2002-2004 in Quebec hospitals, where hundreds of patients were infected and several deaths occurred. The CDC also reported outbreaks of NAP1/BI/027 in several states in 2004.

While Dificid is not yet approved for sale in Canada, Optimer is currently in consultation with Health Canada to determine if Dificid can offer some assistance to combat NAP1/BI/027. In the clinical studies, about 35% of the patients had the NAP1/BI/027 strain of C.difficile. Analysis of the data from two of the clinical trials showed that further investigation is required: one study showed Dificid was superior to vancomycin for reducing recurrences of the hypervirulent strain, but the other study showed equal results.

Update: Dificid tablets were approved by Health Canada on July 5, 2012, the first new treatment for C. difficile infection in Canada in over 20 years. “Awareness of the burden of CDI on the Canadian health care system is high with many health care providers, patients, and caregivers impacted by this devastating infection,” said Paulash Mohsen, President and Country Manager for Optimer Canada. “This familiarity with CDI will help us as we make DIFICID available to Canadian patients in need.”

News flash! HRT is no longer recommended for post-menopausal women, because the health risks outweigh the benefits.

The U.S. Preventive Services Task Force has just issued an updated statement, which you can review here. The recommendation is based on research published since 2005 and it applies to postmenopausal women who are considering hormone therapy to prevent coronary heart disease, dementia and osteoporosis. It does not apply to women who are managing symptoms of menopause, such as hot flashes or vaginal dryness, nor does it apply to women under the age of 50 who have had a hysterectomy.

What’s the upshot of the new recommendation? The USPSTF finds that the potential benefits of combination estrogen and progestin therapy do not outweigh the risks. Specifically, although this combination hormone therapy decreases the risk of fractures, there is an increase in risk for stroke, invasive breast cancer, dementia, gallbladder disease, deep venous thrombosis, pulmonary embolism and urinary incontinence.

The USPSTF also recommends against the use of estrogen therapy alone for chronic disease prevention in postmenopausal women who have had a hysterectomy, because the reduction in risk of fractures and small reduction in the risk for invasive breast cancer are outweighed by an increased risk of stroke, DVT, gallbladder disease and urinary incontinence.

What are the chances that postmenopausal women will suffer from chronic medical conditions as they age?

“The average U.S. woman who reaches menopause is expected to live another 30 years. During her remaining life span, the estimated risk for a chronic medical condition is approximately 30% for coronary heart disease (CHD), 22% for dementia, 21% for stroke, 15% for hip fracture, and 11% for breast cancer.” ( “Menopausal Hormone Therapy for the Primary Prevention of Chronic Conditions: U.S. Preventive Services Task Force Recommendation Statement, Annals of Internal Medicine, October 23, 2012)

There is no magic medication to ensure healthy aging. The USPSTF recommends that women with osteoporosis seek proven interventions to treat low bone density, such as weight-bearing exercise, bisphosphonates and calcitonin. For those who are at a greater risk of developing breast cancer, they recommend considering tamoxifen or raloxifene treatments, taking the risk factors for stroke and thrombosis into account.

Oh, and in case you are wondering, the USPSTF did not identify any randomized clinical trials that evaluated the potential benefits or harms of compounded bioidentical hormones for the prevention of chronic conditions in postmenopausal women. They refer to the FDA’s position, which is that “bioidentical hormone therapy” is a marketing term rather than an approved drug classification and that there is no bioidentical hormone therapy that has been evaluated for safety or effectiveness, nor approved.

Imagine in the future, if your surgeon could seal your incision using just a special dye and a non-thermal laser light – no sutures, staples or glues required. This technology could be available sooner than you think, because the Department of Defense (DoD) has been funding research for photochemical tissue bonding (PTB) for more than 8 years.

PTB involves using a light-sensitive dye and non-thermal light source to create a strong, watertight bond for tissue repair. The bond is superior to traditional closure methods because there is no inflammation and less scarring. PTB has shown promise for a variety of tissue repairs, such as closure of skin incisions and corneal surgeries.

Dr. Irene Kochevar says, “The human clinical study using the PTB technique for closure of skin excisions is showing promising initial results,” so she anticipates that an application for FDA approval will be filed in a few months. Kochevar is a photochemist and biochemist with the Wellman Center for Photomedicine at Massachusetts General Hospital and professor at Harvard/MIT Division of Health Sciences Technology.

Eye injury is a significant civilian health issue in the United States – there are more than 2. 5 million eye injuries annually, happening either in the home, during sports, at work, or during motor vehicle accidents. Eye injuries also represent a significant and rising percentage of battlefield injuries among soldiers in active duty, especially in recent conflicts in Iraq and Afghanistan where IEDs (improvised explosive devices) have become the weapon of choice.

Under the same DoD funding umbrella as the skin PTB project, Kochevar and her colleague, Dr. Robert Redmond are moving forward on two other priority studies, in collaboration with Dr. Anthony Johnson at the Brooke Army Medical Centre in San Antonio, Texas. They are looking for ways to use PTB to improve eye surgery techniques:

1. Penetrating Eye Wounds – Amnion, a patch of amniotic membrane, is currently used in civilian eye surgery, but the current technique requires the time-consuming use of tiny hairline sutures to connect the amnion to the sclera or cornea. Kochevar says, “With PTB, the patch could be applied quickly to seal the eye to maintain ocular pressure and prevent fluids from leaking out while other more critical trauma care is performed on a wounded soldier. The patch could be applied by any medic, not necessarily an ophthalmologist or cornea specialist, and could remain in place for a day or two until the injured soldier can be seen by a specialist.”

An amnion patch applied with PTB might work well with irregularly-shaped or stellate wounds. So far this research has only been conducted on rabbits. Kochevar hopes the project earns FDA approval down the road because the PTB technique would be much easier for ophthalmologists to perform and may reduce inflammation and scarring for the patient.

2. Preventing Cornea Damage in Burn Victims – Burned facial skin tends to pull and tighten as it heals, making it difficult to blink. Burn victims may lose their corneas and require transplant surgery if they can’t keep their corneas moist. The problem with using amnion applied with current technology is that the eye produces enzymes after a day or two to try to dissolve the foreign material.

Researchers hope that PTB technology will stabilize the amnion so that it can be left in place for a week or two, saving money, time and corneas. Dr. Anthony Johnson is currently setting up the animal model for testing, and Kochevar says they have worked out ways to crosslink proteins in the amnion to prevent eye enzymes from dissolving it.

Meeting the demand with 30-year knee implants and new surgical techniques

“The majority of people coming into my office for knee replacement surgery are in their 50s,” says Steven Haas MD, Chief of Knee Surgery and Attending Orthopedic Surgeon at the Hospital for Special Surgery in New York City. This is a big shift in demand compared to 20 years ago, when fewer than 10% of knee replacement patients were in their 50s.

Innovative technologies in implant design and surgical techniques are meeting the growing demand for knee replacements among active Baby Boomers, providing both longer-lasting results and a faster recovery.

The FDA recently cleared a 30-year knee implant, based on simulated wear tests that showed an 81% reduction in wear, the leading cause of knee replacement failure. The implant uses VERILAST technology – a combination of oxidized zirconium (OXINIUM) for the femoral component and cross-linked polyethylene (XLPE) on the tibial side. As older knee implants made from chrome cobalt metal usually lasted only about 10-15 years, surgeons were reluctant to put them into people under 60 years old – they tried to match the implant survivor curve to the predicted lifespan of the patient.

Dr. Haas says that more recent knee implants are more functional than earlier versions, because the design has come a long way to fit the anatomy of the patient as closely as possible and provide a more natural articulation compared to the first knee implants that only hinged and were the same for both left and right sides.

Surgeons are also now using smaller instruments and minimally invasive surgical techniques to minimize trauma to the patient, leading to faster recovery. Dr. Hass developed the first minimally invasive surgical instruments in 2003. He says, “What we want to do is cut as little as possible to put the parts in, to do as little collateral damage to get access and minimize the trauma. With more anatomically shaped instruments, we are making the instruments fit the opening instead of the opening fit the instrument.”

Minimally invasive surgical techniques involve using smaller incisions to access the knee area after the patient receives a local anesthetic via epidural. The knee replacement operation is performed without needing to cut the quadriceps tendon or flip the kneecap upside down to gain access, as was required with older surgical techniques. Recoveries for patients who receive the minimally invasive surgical technique are significantly faster: most patients are able to resume their activities 6 weeks after surgery rather than 3 months.

Longer lasting implants and a quick recovery are appealing considerations for Baby Boomers, especially since the need for knee replacement is on the rise for that age group. Those in their 50s in general are more active than people in that group were a generation ago and they expect to maintain that active lifestyle for as long as possible. Expectations for the variety of activities have changed as well. Dr. Hass reports that Baby Boomers won’t settle for just walking around the block, “they want to be able to bike, hike, play tennis, ski, dance and play with their kids.”

All of this was good news for Jane Byron, age 51, a nurse who had both knees replaced in 2010 by Haas. An extremely active person who works on her feet and works out at the gym everyday, Jane tore her meniscus in a rollerblading accident. Subsequent arthroscopic surgery did not address her mobility issues. After minimally invasive surgery with new knee implants, she was pedaling a stationary bike for 45 minutes two days after surgery and pressing 75 pounds on the squat rack two months later.

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